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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name eye, artificial, non-custom
510(k) Number K952538
Device Name ROBERT B. SCOTT PLASTIC ARTIFICAL
Applicant
ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
3500 EAST FLETCHER AVE.
SUITE 502
TAMPA,  FL  33613
Applicant Contact RANDAL E MINOR
Correspondent
ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
3500 EAST FLETCHER AVE.
SUITE 502
TAMPA,  FL  33613
Correspondent Contact RANDAL E MINOR
Regulation Number886.3200
Classification Product Code
HQH  
Date Received05/31/1995
Decision Date 06/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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